Evaluation of Corneal Staining With Various Contact Lens/Solution Combinations

Corneal Staining Clinical Trial

Official title:

Evaluation of Corneal Staining With Market Contact Lens/Solution Combinations

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00381446
• Other study ID #: MS005
• Status: Recruiting
• Phase: N/A
• First received: September 25, 2006
• Last updated: September 26, 2007
• Start date: July 2005
• Est. completion date: March 2008

Study information

• Verified date: September 2007
• Source: Andrasko, Gary, OD, LLC
• Contact: Gary J. Andrasko, OD, MS
• Phone: 614-459-3363
• Email: gandrask[@]columbus.rr.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to quantify the amount of corneal staining observed with various marketed contact lens/multipurpose solution combinations. The hypothesis is that there are measurable differences in the amount of corneal staining between the various combinations.

Description:

A series of clinical studies is being conducted at one research site using a double-masked, randomized cross-over design. Each study consists of asymptomatic daily wear soft contact lens wearers observed at baseline and at two and four hours post lens insertion. Corneal staining is being assessed using sodium fluorescein, a cobalt filter and a yellow filter. Subjective comfort assessments are obtained at each visit.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• currently wearing soft contact lenses daily wear for at least 2 weeks prior to study

• correct visual acuity of 20/30 or better each eye

Exclusion Criteria:

• history of hypersensitivity to any components of solution being tested

• any ocular condition prohibiting contact lens wear

• excessive baseline staining as defined in protocol

• use of topical or OTC ocular medications during the study

• seasonal allergies with significant effect on contact lens wear

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Corneal Epithelial Disruption
• Corneal Staining

Intervention

Device:
• Marketed contact lens care products

Locations

Country	Name	City	State
United States	Dr. Richard Erdey office	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Andrasko, Gary, OD, LLC	Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area of Corneal Staining
Secondary	Type (severity) of Corneal Staining